FDA declined to codify new asthma phenotype in the indication for GSK's Nucala, leaving emerging definition of eosinophilic asthma to the medical community. For FDA's endorsement, it is not enough to show that patients with eosinophilia biomarkers benefit; you also need to show that patients without the biomarker do not benefit.
FDA's approval of GlaxoSmithKline PLC's Nucala is a big step toward recognition of a severe asthma phenotype characterized by elevated eosinophils, but the agency chose to defer to the medical community on the task of how to use the biomarker to identify patients.
"Consensus on defining patients based on an eosinophilic characteristic has been challenging," Office of Drug Evaluation II Deputy Director Mary...
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
